Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Melanoma (Skin)
Intervention: Candida albicans skin test reagent (Drug); MART-1 antigen (Drug); aldesleukin (Drug); gp100 antigen (Drug); recombinant CD40-ligand (Drug); recombinant interferon gamma (Drug); recombinant interleukin-4 (Drug); sargramostim (Drug); therapeutic autologous dendritic cells (Drug); therapeutic tumor infiltrating lymphocytes (Drug); tyrosinase peptide (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Norris Comprehensive Cancer Center Official(s) and/or principal investigator(s):
Jeffrey S. Weber, MD, PhD, Study Chair, Affiliation: Norris Comprehensive Cancer Center
Summary
RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to
kill tumor cells. Biological therapies such as interferon gamma and interleukin-2 use
different ways to stimulate the immune system and stop cancer cells from growing. Combining
vaccine therapy with biological therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying giving vaccine therapy together with interferon
gamma and interleukin-2 in treating patients with stage III or stage IV melanoma.
Clinical Details
Official title: A Phase II Trial of a MART-1/gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Treated With CD40 Ligand/Gamma Interferon With Subcutaneous IL-2 for Patients With Metastatic Melanoma
Study design: Treatment
Detailed description:
OBJECTIVES:
- Determine the clinical response rate and immune response in HLA-A2 positive patients
with stage III or IV melanoma after receiving autologous dendritic cells pulsed with
melanoma antigen peptides (MART-1: 26-35, gp100: 209-217, and tyrosinase: 368-376) and
treated ex vivo with CD40-ligand and interferon gamma, followed by interleukin-2 in
vivo.
- Determine the toxicities of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients undergo leukapheresis to harvest autologous dendritic cells (ADCs). Melanoma
peptides (MART-1: 26-35, gp100: 209-217, and tyrosinase: 368-376) are pulsed separately onto
ADCs, which are also treated ex vivo with CD40-ligand, interferon gamma, interleukin-4,
sargramostim (GM-CSF), and Candida albicans skin test reagent. Patients receive each melanoma
peptide pulsed ADC vaccine separately via 3 successive 10 minute infusions on day 1. Patients
then receive interleukin-2 subcutaneously every 12 hours on days 2-6. Treatment repeats every
2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks, then every 3 months for 2 years, then every 6 months for 3
years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 18-24
months.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic melanoma
- Measurable disease after attempted curative surgery
- Unresectable stage III or IV uveal melanoma
- Metastatic mucosal melanoma
- HLA-A2. 1 positive
- No disease progression following high dose interleukin-2 (600,000 or 720,000 IU/kg
every 8 hours)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 75,000/mm^3
- Hemoglobin at least 9. 0 g/dL
- No coagulation disorders
Hepatic:
- Bilirubin no greater than 2. 0 mg/dL
Renal:
- Creatinine no greater than 2. 0 mg/dL
Cardiovascular:
- No myocardial infarction within the past 6 months
- Patients with documented or suspected coronary artery disease must undergo stress
thallium test
- No major cardiovascular illness
Pulmonary:
- No major pulmonary illness
Immunologic:
- HIV negative
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
- No history of uveitis or autoimmune inflammatory eye disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No major systemic infection
- No other malignancy within the past 5 years except curatively treated carcinoma in
situ of the cervix or basal cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- No prior MART-1: 26-35, gp100: 209-217, or tyrosinase: 368-376 antigens
Chemotherapy:
- At least 1 month since prior chemotherapy for melanoma
Endocrine therapy:
- No concurrent steroid therapy
Radiotherapy:
- At least 1 month since prior radiotherapy for melanoma
Surgery:
- See Disease Characteristics
Other:
- At least 1 month since prior adjuvant therapy for melanoma
- At least 1 month since other prior therapy for melanoma
Locations and Contacts
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California 90089, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: June 1999
Last updated: May 23, 2008
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